Aubagio (teriflunomide) Tablets

How do I take it?

• Aubagio tablets can be taken with or without food.
• The usual dose is one tablet taken once daily with a glass of water. You can take your tablet at any time of day. However, if you always take your tablet at the same time each day it will help you remember it.
• If you forget to take a tablet you should just take your next dose as usual the following day. Don't take a double dose to make up for a missed dose.
• The medicine is taken every day on a regular basis until you and your doctor decide that it is time to stop.

Warning!

• Your doctor will want you to have blood tests to check your liver function before starting treatment with this medicine and regularly while you continue to take it. You should tell your doctor if you experience any unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, jaundice and/or dark urine while taking this medicine, as these could be signs of a problem with your liver.
• You should avoid drinking large amounts of alcohol while you are taking this medicine because this could increase the risk of side effects on your liver.
• This medicine can decrease the number of white blood cells in your blood, which can increase your susceptibility to infections. For this reason, you should tell your doctor immediately if you experience any symptoms of infections while you are taking this medicine, for example high temperature (fever), flu-like symptoms, sore throat, mouth ulcers, cold sores, athlete’s foot, cystitis, sickness and diarrhoea or any other signs of infection. Your doctor may need to take a blood test to check your blood cells.
• This medicine can cause your blood pressure to rise and your doctor will want to check your blood pressure before you start treatment and regularly while you continue to take the medicine. If your blood pressure rises you may need to take extra medicines to control it.
• Although serious skin reactions have not been reported with this medicine, they have been very rarely reported with a related medicine. For this reason you should tell your doctor if you experience skin reactions such as a rash, blistering or peeling of the skin, or sores inside your mouth while taking this medicine.
• This medicine may be harmful to an unborn baby. Women taking this medicine who could get pregnant must use an effective method of contraception to prevent pregnancy. You will be given advice on which forms are suitable for you. Contraception should be started before your treatment begins and be continued all the time you are taking this medicine. You should continue to use contraception to prevent pregnancy for at least two years after you stop taking this medicine. You should consult your doctor immediately if you think you could be pregnant. See the pregnancy section below for further information.
• Teriflunomide takes a long time to be naturally removed from the body after treatment is stopped and can last for up to two years in the body after you stop taking it. It may sometimes be necessary to take other medicines to help speed up the removal of teriflunomide from the body after stopping treatment. This is especially important if serious side effects have been experienced, or if you are planning a pregnancy.

Use with caution in

• People over 65 years old.
• People who drink large amounts of alcohol.
• People with liver disease.
• People with high blood pressure (hypertension).
• People with a history of tuberculosis infection.

Not to be used in

• People whose immune systems have a decreased ability to fight infection and disease, eg due to conditions such as AIDS or immunodeficiency syndromes, or treatment with medicines such as chemotherapy or immunosuppressants.
• People with severe active infections or long-standing infections such as hepatitis or tuberculosis.
• People with low numbers of red blood cells (anaemia), white blood cells (leucopenia or neutropenia) or platelets (thrombocytopenia) in their blood, or problems with their bone marrow.
• People with unusually low amounts of protein in their blood (hypoproteinaemia), eg due to the kidney disorder nephrotic syndrome.
• People with severely decreased liver function.
• People with severely decreased kidney function who are having dialysis.
• Women who could get pregnant.
• Pregnancy.
• Breastfeeding.
• People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Aubagio tablets contain lactose).

The safety and effectiveness of this medicine have not been established in children and adolescents under 18 years of age. It is not recommended for this age group.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy as it could be harmful to a developing baby. Before you start treatment your doctor may want to do a pregnancy test to make sure that you are not pregnant.

• Women who could get pregnant should use an effective method of contraception to prevent pregnancy, both during treatment and after stopping treatment, until the levels of this medicine in your blood have fallen low enough to not be a risk to a developing baby. This can take up to two years after stopping treatment. The level of medicine in your blood can be confirmed with a blood test.
• If you think you could be pregnant at any point during treatment or in the two years after stopping treatment, or if you want to plan a pregnancy after stopping treatment, you should tell your doctor straight away. It is possible to speed up the removal of the medicine from the blood by taking certain other medicines. Seek further medical advice from your doctor.

Teriflunomide may pass into breast milk and could have unwanted effects on a nursing infant. Women who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common

• Diarrhoea.
• Feeling sick.
• Hair loss (alopecia).
• Increased liver enzymes.

Common 

• Flu infections (influenza).
• Infections in the nose or throat, eg sinusitis, pharyngitis, laryngitis.
• Infection in the lungs eg bronchitis.
• Urinary tract infections such as cystitis.
• Tooth infections.
• Herpes simplex infections, such as cold sores.
• Gastroenteritis.
• Athlete's foot.
• Low numbers of white blood cells in the blood (neutropenia). 
• Low numbers of red blood cells in the blood (anaemia).
• Pins and needles or tingling sensations. Tell your doctor if you experience this.
• Sciatica.
• Carpel tunnel syndrome.
• High blood pressure.
• Abdominal pain and being sick (vomiting).
• Toothache.
• Pain in the muscles, joints or bones.
• Increased need to pass urine.
• Heavy periods (menorrhagia).
• Rash.
• Acne.
• Anxiety.

Uncommon 

• Low numbers of platelets in the blood (thrombocytopenia).
• Damage to nerves that lie outside the brain and spinal cord (peripheral neuropathy). This may cause symptoms such as burning or shooting pains, weakness, or increased sensitivity of nerves to touch. Tell your doctor if you experience anything like this.

Very rare 

• Inflammation of the pancreas (pancreatitis).
• Interstitial lung disease. Tell your doctor if you develop a persistent cough or breathing difficulties while you are taking this medicine.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Teriflunomide may increase the blood levels of the following medicines. As this could increase the risk of their side effects, your doctor may need to reduce the dose of these medicines if you take them in combination with Aubagio tablets:

• cefaclor
• ethinylestradiol (found in some oral contraceptives)
• levonorgestrel (found in some oral contraceptives)
• methotrexate
• paclitaxel
• pioglitazone
• repaglinide
• rosiglitazone
• rosuvastatin (decrease in dose of rosuvastatin is recommended)
• other statins such as simvastatin, atorvastatin, pravastatin.

Teriflunomide may decrease the level of the following medicines in the blood and could theoretically make them less effective:

• duloxetine
• theophylline
• tizanidine.
• Teriflunomide may decrease the anti-blood-clotting effect of warfarin. Your doctor may want to check your blood clotting time (INR) more frequently if you take this medicine with warfarin.

The following medicines may decrease the level of teriflunomide in the blood and could make it less effective:

• carbamazepine
• phenytoin
• phenobarbital
• rifampicin
• the herbal remedy St John’s wort (Hypericum perforatum).

Colestyramine and activated charcoal can significantly decrease the blood level and effect of teriflunomide. These medicines should not be taken in combination with teriflunomide unless they have been specifically prescribed to speed up the removal of the teriflunomide from the body.

This medicine suppresses part of the immune system. This means that vaccines may potentially be less effective if given during treatment and live vaccines could cause serious infections, though this has not been studied. Live vaccines should be avoided while you are taking this medicine; these include measles, mumps, rubella, MMR, oral polio, oral typhoid, shingles, chicken pox, BCG and yellow fever vaccines.

References:

https://www.medicines.org.uk/emc/product/5244/smpc

https://www.netdoctor.co.uk/medicines/brain-nervous-system/a8919/aubagio-teriflunomide/

https://www.aubagio.com

https://www.webmd.com/drugs/2/drug-162505/aubagio-oral/details

https://www.mstrust.org.uk/a-z/aubagio-teriflunomide

https://www.nationalmssociety.org/Treating-MS/Medications/Aubagio